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The number of cases of diabetes and prediabetes among Americans of all ages and ethnicities continues to increase, according to the National Diabetes Statistics Report, 2014 (based on health data from 2012), released today by the Centers for Disease Control and Prevention. People with diabetes often use a blood glucose monitoring device to help them maintain healthy glucose levels.
Senior man using glucometer: Maintaining a healthy blood glucose level helps people with diabetes stay healthy. Biographya€?These new numbers are alarming and underscore the need for an increased focus on reducing the burden of diabetes in our country.
Biographya€?If we want to reduce the overall burden of diabetes in our nation, we have to focus on preventing diabetes in the first place."a€?The number of people affected by diabetes and prediabetes has increased across all age groups and ethnicities.
Science, Technology and Medicine open access publisher.Publish, read and share novel research. Effectiveness of Fenugreek for Lowering Hemoglobin (HbA1c) in Patients with Self-Management of Type 2 Diabetes: A Randomized Controlled TrialRashid Ansari1 and Saiqaa Ansari2[1] School of Public Health, University of New England, Australia[2] School of Population Health, University of Queensland, Australia1. Gestational diabetes mellitus (GDM) is a condition in women who have carbohydrate intolerance with onset or recognition during pregnancy.
The prevalence of GDM varies in direct proportion to the prevalence of type 2 diabetes in a given population or ethnic group. The incidence of gestational diabetes mellitus (GDM) is on the increase and, if not diagnosed, managed and treated adequately, can have unfavorable maternal and fetal outcomes.
The offspring of women with GDM are at increased risk of macrosomia, neonatal hypoglycemia, hyperbilirubinemia, operative delivery, shoulder dystocia, and birth trauma. Historically, screening for GDM consisted of obtaining the patient’s medical history, relying primarily on past obstetric outcomes and a family medical history of type 2 diabetes. The use of traditional historic factors (family or personal history of diabetes, previous adverse pregnancy outcome, glycosuria, and obesity) to identify GDM will miss approximately one half of women with GDM.
The American College of Obstetricians and Gynecologists mentions the following clinical considerations and recommendation about diagnosing GDM in its practice bulletin (reaffirmed 2015). All pregnant patients should be screened for GDM, whether by the patient’s medical history, clinical risk factors, or laboratory screening test results to determine blood glucose levels.
A one-step approach to establishing the diagnosis of GDM using a 75-g, 2-hour OGTT has been used and promoted by other organizations. There are no data from randomized clinical trials (RCTs) regarding therapeutic interventions for the expanded group of women designated as having GDM based on the International Association of Diabetes and  Pregnancy Study Group criteria. In 2013, a Eunice Kennedy Shriver National Institute of Child Health and Human Development Consensus Development Conference on diagnosing gestational diabetes recommended that health care providers continue to use a two-step approach to screen for and diagnose GDM because no evidence exists that using these 2-hour OGTT criteria to diagnose GDM would lead to clinically significant improvements in maternal or newborn outcomes, but would lead to a significant increase in health care costs. Table 1 lists the diagnostic thresholds established by both the National Diabetes Data Group and those established by Carpenter and Coustan, with the latter using lower thresholds and subsequently resulting in higher rates of GDM diagnoses.
The American College of Obstetricians and Gynecologists mentions the following recommendations and conclusions in its practice bulletin (reaffirmed 2015). Women in whom GDM is diagnosed should be treated with nutrition therapy and, when necessary, medication for both fetal and maternal benefit.
When pharmacologic treatment of GDM is indicated, insulin and oral medications are equivalent in efficacy, and either can be an appropriate first-line therapy. Women with GDM should be counseled regarding the option of scheduled cesarean delivery when the estimated fetal weight is 4,500 g or more. In the absence of clear comparative trials, one set of diagnostic criteria for the 3-hour OGTT cannot be clearly recommended above the other. Once a woman with GDM begins nutrition therapy, surveillance of blood glucose levels is required to be certain that glycemic control has been established. Women with GDM with good glycemic control and no other complications can be managed expectantly.
Postpartum screening at 6–12 weeks is recommended for all women who had GDM to identify women with DM, impaired fasting glucose, or IGT. Pregnancy Care, Problems During Pregnancy, Special Procedures 1-hour oral glucose tolerance test, 2-hour oral glucose tolerance test, 3-hour oral glucose tolerance test, Gestational Diabetes Mellitus (GDM), Screening for and Diagnosis of GDM. Diabetic retinopathy is the most common diabetic eye disease caused by changes in the retinal blood vessels.
In diabetic retinopathy, the retinal blood vessels may swell and leak in some patients, while in others new vessels can grow on the surface of the retina too, resulting in loss of light sensitivity of retina, affecting vision. As the name indicates, people with diabetes (both type 1 and type 2) are at risk of developing diabetic retinopathy. Pregnancy can precipitate the diabetic retinopathy therefore pregnant diabetic women are advised to undergo eye examinations in each trimester.
People with Down’s syndrome having 3 copies of chromosome 21 almost NEVER acquire diabetic retinopathy! If you experience any of the symptoms of diabetic retinopathy consult your eye specialist as soon as possible to have a comprehensive eye examination. Note that the above mentioned options simply slow down the progress of disease or may even stop it, but they don’t treat the damage already occurred and can’t reverse it. Low Vision SpecialistsIf you or a loved one have vision loss, call today for a free phone consultation.
Low Vision Specialists Specialists of Maryland and Virginia servicing Annapolis, Baltimore, Bethesda, Columbia, Rockville, Silver Spring, Towson, and other locations. Serving the following areas since 1975 MARYLAND: Annapolis, Baltimore, Bel Air, Bethesda, Bowie, Carney, Cockeysville, Columbia, Crofton, Elkton, Essex, Fallston, Fredrick, Gaithersburg, Glen Burnie, Glenwood, Hampstead, Havre de Grace, Jarrettsville, Kingsville, Laurel, Lutherville, Manchester, Monkton, Parkton, Parkville, Perry Hall, Phoenix, Pikesville, Potomac, Randallstown, Reisterstown, Rockville, Severn, Severna Park, Silver Spring, Sparks-Glencoe,Sparrows Point, Towson, Westminster, and Whitemarsh.
The TDC meets quarterly and advises the state on legislation and services to effectively reduce the health and economic burdens of diabetes in Texas.
The Council will hear presentations from the Texas Health and Human Services Commission (HHSC) on Rider 84, the “Texas Medicaid and Texas Diabetes Council Coordination to Improve Screening for Diabetes and Referral of Diabetes to Self-Management Education among Medicaid Patients” report to the Legislature. People with diabetes are at increased risk of serious health complications including blindness, heart disease, stroke, kidney failure, amputation of toes, feet or legs, and premature death.
IntroductionThe incidence of type 2 diabetes is increasing worldwide, resulting in large measure from the increasing prevalence of obesity (Yale, 2000). With the increase in obesity and sedentary lifestyle, the prevalence of DM among reproductive-aged women is increasing globally.
It has been estimated that up to 6–7% of pregnancies are complicated by diabetes mellitus (DM) and that approximately 90% of these cases represent women with GDM.
Women with GDM are at higher risk of gestational hypertension, Preeclampsia, and cesarean delivery and its associated potential morbidities. The relationship between maternal hyperglycemia and fetal macrosomia, as well as other adverse outcomes, has been confirmed in the Hyperglycemia and Adverse Pregnancy Outcome study.
In 2010, the International Association of Diabetes and Pregnancy Study Group convened a workshop conference to recommend new diagnostic criteria based on the Hyperglycemia and Adverse Pregnancy Outcome study data. These additional women in whom GDM would be diagnosed may be at a lower risk of adverse outcomes than women in whom GDM was diagnosed by traditional criteria and may not derive similar benefits from interventions. The American College of Obstetricians and Gynecologists supports this recommendation and recommends that before the testing approach and diagnostic criteria for GDM are changed, implications of such changes should be studied.
There are no randomized trials to support a clear benefit to one cutoff compared with others. In the absence of clear comparative trials, one set of diagnostic criteria for the 3-h OGTT cannot be clearly recommended above the other. However, given the benefits of standardization, practitioners and institutions should select a single set of diagnostic criteria, either plasma or serum glucose levels designated by the Carpenter and Coustan criteria or the plasma levels established by the National Diabetes Data Group, for consistent use within their patient populations. In most cases, women with good glycemic control who are receiving medical therapy do not require delivery before 39 weeks of gestation.
Women with impaired fasting glucose or IGT or diabetes should be referred for preventive therapy. Therefore anyone with diabetes should be vigilant about any vision related changes and issues and get a detailed eye examination regularly every year at least. This is believed to be due to elevated endostatin levels which is an anti-angiogenic protein derived from a collagen located on chromosome 21. Your doctor should take a detailed history, including family history, and do various tests at your eye examination. There are certain other treatments that seem promising but are under trial and development phases. More than 10 percent of adult Texans have diagnosed diabetes, according to the most recent CDC report. Ita€™s urgent that we take swift action to effectively treat and prevent this serious disease."a€?Now is the time to take action. Diabetes mellitus is a pandemic disease and is one of the main threats to human health (Narayan, 2005). In view of the increasing prevalence of GDM and fetal and neonatal complications associated with it, there is a splurge of research in this field and management of GDM is undergoing a sea change. As the risk of developing GDM in subsequent pregnancies and also the risk of overt diabetes in later life is high, regular assessment of these women is required in future. Most importantly, women with GDM have an increased risk of developing diabetes later in life.
This test has become widely used—an estimated 95% of obstetric groups in the United States report performing universal screening using the 50-g, 1-hour oral glucose tolerance test. Early pregnancy screening for undiagnosed type 2 diabetes, also is suggested in women with risk factors, including those with a prior history of GDM (see Box 1). Data also are insufficient with regard to pregnancy outcomes to determine an ideal threshold value, although standardization of a screening threshold has been recently recommended.
The ADA recommends repeat testing at least every 3 years for women who had a pregnancy affected by GDM and normal results of postpartum screening. This number has nearly doubled since 1994 when only 5.8 percent of the adult population had diagnosed diabetes. If these numbers continue to rise, 1 in 5 people could have diabetes by the year 2025, and it could be 1 in 3 people by the year 2050.
Goals of metabolic management of a pregnancy complicated with GDM have to balance the needs of a healthy pregnancy with the requirements to control glucose level. It is projected that up to 50% of women with GDM will develop diabetes 22–28 years after pregnancy. However, consistent data that demonstrate an overall benefit to screening all pregnant women for GDM are lacking.
If the result of early testing is negative, repeat screening for high-risk women is recommended at 24–28 weeks of gestation. The American Diabetes Association (ADA) endorsed the International Association of Diabetes and Pregnancy Study Group criteria while acknowledging that adopting these cutoffs will significantly increase the prevalence of GDM.


In one cross-sectional study that compared the two sets of criteria in more than 26,000 women, the diagnosis of GDM increased, on average, by 50% with the use of the Carpenter and Coustan thresholds. We simply cana€™t sustain this trajectory a€“ the implications are far too great a€“ for our families, our healthcare system, our workforce, our nation."a€?We know today that adopting a healthier lifestyle is the most effective way to prevent type 2 diabetes and improve health for people already diagnosed with diabetes. It is projected that this number will be increased by 72% to 333 million by 2025, and nearly 80% of these cases will be in the poorer industrialized countries (IDF, 2003).
The progression to type 2 diabetes may be influenced by ethnicity and the incidence of obesity.
The two step approach to testing, commonly used in the United States, is based on first screening with the administration of 50 g of an oral glucose solution followed by a 1-hour venous glucose determination. Considerations for selection of one set of diagnostic criteria over the other could include, but are not limited to, the baseline prevalence of diabetes in their specific communities and the availability of resources to appropriately manage the numbers of women in whom GDM was diagnosed by any given protocol. According to a 2005 US Government estimate, approximately 21 million people in the United States have diabetes (Gerich, 2005).
Those individuals meeting or exceeding the screening threshold undergo a 100-g, 3-hour diagnostic oral glucose tolerance test (OGTT).
This approach, while imperfect, avoids establishment of a single set of diagnostic criteria across all populations based on expert opinion alone. In 2002, diabetes was the sixth leading cause of death and had an estimated total cost of $132 billion (Hogan et al.
Type 2 diabetes is a disease characterized by a dual defect: 1) by insulin resistance which prevents cells from using insulin properly, and 2) degrees of reduced pancreatic insulin secretion. A quarter of the population of Pakistan would be classified as overweight or obese with the use of Indo-Asian-specific BMI cutoff values.
Prevention efforts nationwide are crucial to combat serious health risks.Individuals can learn more about diabetes and prediabetes by talking to a healthcare provider about the risk to them and their families. Jafar et al (2006) have reported that prevalence of overweight was 25% and obesity was 10% in a large population-based sample of people over the age of 15 years in Pakistan. Learn more about diabetes and CDCa€™s evidence-based and cost-effective interventions through our National Diabetes Prevention Program.
On the age-specific prevalence of overweight and obesity, they found that more than 40% of women and 30% of men aged 35–54 years were classified as overweight or obese. It has been suggested in a variety of observational and epidemiological studies that physical activity may play a significant role in the prevention of type 2 diabetes mellitus. The relationships between physical activity and overweight are only beginning to be understood for the adult population, sedentary behaviours, particularly watching television (TV) and videos, surfing the internet have been found to be related to higher body mass index (BMI) for adult’s population (Struber, 2004). The literature linking physical activity levels with risk of overweight in adults is not consistent but physical activity is an important component of effective obesity treatments (Saelens, 2003). The main health promotion intervention here is the public health education which highlights the importance of physical activity for the prevention of type 2 diabetes in the middle-aged population of sub-continent and particularly Pakistan, which is experiencing a rapid and substantial decline of physical activity levels as a result of poor eating habits, unhealthy food supply, expansion of television, computerization, and mechanization, more prevalent car ownership and sedentary behaviour. In parallel with decreasing levels of physical activity, the prevalence of overweight and obesity has increased significantly in Pakistan and as a consequence, diabetes mellitus has become a major public health issue. Therefore, promoting an active lifestyle or regular exercise has become the highest public health priority in that country to overcome the onslaught of type 2 diabetes.
Also, the search for dietary adjuncts along with usual medical care to treat this life altering disease has become more important and dietary supplements that can modulate glucose homeostasis and potentially improve lipid parameters would be desirable. Fenugreek (Trigonella foenum-graecum Linn) is a dietary supplement that may hold promise in this regard and is one of the oldest medicinal plants, originating in India and Northern Africa and dating back to ancient Egyptian times (Jensen, 1992).In Pakistan and India, fenugreek is commonly consumed as a condiment (Yoshikawa et al. Fenugreek seeds also lower serum triglycerides, total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (Al-Habori and Raman, 1998). The lipid-lowering effect of fenugreek might also be attributed to its estrogenic constituent, indirectly increasing thyroid hormones (Basch, 2003). The plant protein in fenugreek is 26%, so it might exert a lipid lowering effect (Sharma, 1986). Since a high proportion of diabetic patients in sub-continent suffer from malnutrition, the use of fenugreek which is rich in protein and fiber (48%), has a distinct advantage in these patients (Sharma, 1986).
This chapter addresses the effectiveness of fenugreek for lowering hemoglobin (HbA1c) in this randomized controlled trial and determines whether the intervention of taking fenugreek in combination of usual medical care lowers HbA1c in patients with type 2 diabetes. Effectiveness trials such as this are critical in determining if the interventions are effective in the practical world in which patients live. This randomized control trial addresses the research question “Is Fenugreek treatment with medical care for patients with type 2 diabetes more effective than usual medical care and can it help to lower the haemoglobin in patients with poorly controlled type 2 diabetes”? Characteristics of type 2 diabetesType 2 diabetes is associated with certain ethnic groups, obesity, family history of diabetes, and physical inactivity, among other factors. Chronic, untreated hyperglycemia can lead to serious complications that include cardiovascular diseases, blindness, kidney failure, and stroke.
Furthermore, very low values of blood glucose (hypoglycemia) for even a short duration can result in loss of consciousness and coma. The figure 1 shows the complications of type 2 diabetes which is a syndrome characterized by insulin deficiency, insulin resistance, and increased hepatic glucose production. These metabolic abnormalities are treated by use of various medications which are designed to correct one or more of these metabolic abnormalities (Saltiel & Olefsky, 2001). Type 2 diabetes is most common in adults, although younger people are also developing this type of disease. It starts with a slow onset with thirst, frequent urination, weight loss developing over weeks to months. It is also considered to run in families but it may happen with a person without a family history of diabetes as well. In its early stages, many people with type 2 diabetes can control their blood glucose levels by losing weight, eating properly and exercising. Many may subsequently need oral medication, and some people with type 2 diabetes may eventually need insulin shots to control their diabetes and avoid the disease's serious complications (Saltiel & Olefsky, 2001). Even though there is no cure for diabetes, proper treatment and glucose control enable people with type 2 diabetes to live normal, productive lives. A major advance for people at risk of developing type 2 diabetes - such as family members of those with the condition - occurred recently when it was shown that diet and exercise can prevent or delay type 2 diabetes. 2004), however, population-based data on the prevalence of diabetic retinopathy in Pakistan and on the visual impairment due to diabetic retinopathy is lacking and only the hospital-based data is available (Kayani et al. Diabetic nephropathy is present in 18% of people diagnosed with diabetes (DSG, 1993) and is a leading cause of end-stage renal disease (Molitch et al. 2003)Stroke: diabetes is associated with a 2- to 4-fold increase in cardiovascular mortality and stroke (Kannel et al. Therefore, early detection and treatment of diabetes is essential in order to reduce the impact of its serious complications.
Development of type 2 diabetesDevelopment of type 2 diabetes is the result of multifactorial influences that include lifestyle, environment and genetics. The disease arises when insulin resistance-induced compensatory insulin secretion is exhausted.
A high-caloric diet coupled with a sedentary lifestyle is one of the major contributing factors in the development of the insulin resistance and pancreatic ?-cell dysfunction as shown in Figure 2. However, a predisposing genetic background has long been suspected in playing a contributing role in the development of type 2 diabetes. The metabolic syndrome is defined as a clustering of atherosclerotic cardiovascular disease risk factors that include visceral adiposity (obesity), insulin resistance, low levels of HDLs and a systemic proinflammatory state. There are key components to the metabolic syndrome which include in addition to insulin resistance (the hallmark feature of the syndrome), hypertension, dyslipidemia, chronic inflammation, impaired fibrinolysis, procoagulation and most telling central obesity.3. Randomized controlled trials with fenugreekThe multiple trials in the past have shown conflicting results of the effect of fenugreek on the patients of type 2 diabetes. These studies showed some positive results on fasting serum glucose but did not examine hemoglobin (HbA1c) levels. Gupta et al (2001) reported the results of a small randomized, controlled, double-blind trial to evaluate the effects of fenugreek seeds on glycemic control. The authors reported that there were no significant differences between groups in mean glucose tolerance test values at the study's end.
However, the trial may have been too small or brief to detect significant mean differences between groups. Raghuram et al (1994) reported the results of a randomized, controlled, crossover trial of fenugreek seeds in 10 patients with type 2 diabetes. In the fenugreek-treated patients, statistically significant mean improvements were reported for glucose-tolerance test scores and serum-clearance rates of glucose.
Sharma and Raghuram (1990) conducted two randomized, controlled, crossover studies in patients with type 2 diabetes.
Significant mean improvements in fasting blood-glucose levels and glucose-tolerance test results were described in the fenugreek-treated patients. Moosa et al (2006) conducted study to evaluate the effect of fenugreek on serum lipid profile in hypercholesteremic type 2 diabetic patients and concluded that fenugreek seeds powder significantly reduced serum total cholesterol, triglyceride and LDL-cholesterol but serum HDL-cholesterol level elevation was not significant. Neeraja and Rajyalakshmi (1996) presented a case series including six men with type 2 diabetes and six without diabetes. The cases suggested fenugreek reduced postprandial hyperglycemia primarily in subjects with diabetes, but less so in subjects without diabetes. The studies conducted to date have been methodologically weak, lacking adequate descriptions of blinding, randomization, baseline patient characteristics, statistical analysis, and standardization data for the therapy used. Demonstrating the efficacy of fenugreek has also been confounded by inconsistencies in the preparations, dosing regimens, and outcome measures used in the trials.
Moreover, none of the investigations have been conducted over the longer period (Basch, 2003).
Method of patient selectionThe patients were recruited from the diabetic medical centre in rural area of Peshawar conducting the study of management of type 2 diabetes among the population aged 30-65 years. Patients having coexisting liver, kidney or thyroid disorder were not included in the study. Diabetes Criteria for patientsThe well known standard screening test for diabetes, the fasting plasma glucose (FPG), is also a component of diagnostic testing. The FPG test and the 75-g oral glucose tolerance test (OGTT) are both suitable tests for diabetes; however, the FPG test is preferred in clinical settings because it is easier and faster to perform, more convenient and acceptable to patients, and less expensive. When it was found necessary, plasma glucose testing was also performed on individuals who have taken food or drink shortly before testing. Such tests are referred to as casual plasma glucose measurements and are given without regard to time of last meal. A confirmatory FPG test or OGTT was also completed on such patients on a different day if the clinical condition of the patient permits.


Laboratory measurement of plasma glucose concentration is performed on venous samples with enzymatic assay techniques, and the above-mentioned values are based on the use of such methods.
The A1C test values remain a valuable tool for monitoring glycemia, but it is not currently recommended for the screening or diagnosis of diabetes.
Pencil and paper tests, such as the American Diabetes Association’s risk test, may be useful for educational purposes but do not perform well as stand-alone tests. Capillary blood glucose testing using a reflectance blood glucose meter has also been used but because of the imprecision of this method, it is better used for self-monitoring rather than as a screening tool. Determination of study sample size The study sample size was determined based on the assumption of the estimation of Standard Deviation (SD). Therefore, the study design was selected to detect an effect size of 0.5 SD lowering of HbA1c. It was assumed that 15% patients might be lost to follow-up in control group over the period of three months and only 5 % patients will be lost to follow-up in intervention group. This assumption was based on the popularity of fenugreek seeds used by diabetic patients in sub-continent to manage their glycemic control. Study population and randomizationInitially 325 patients with type 2 diabetes were invited to pre-randomized interview, out of which only 210 patients were included in the actual trial. Out of the 325 patients, 93 patients did not meet the inclusion criteria and 22 patients refused to participate in the trial.
Finally, two hundred and ten (210) patients agreed to participate and signed informed consent documents at the clinic where they used to visit for their usual medical care for diabetes. Therefore, 102 patients were randomized to intervention group (fenugreek supplements) and 108 to the control group (usual medical care). The randomization code was developed using a computer random number generator in a block size of eight patients.
That helped to allocate patients to the intervention and control groups equally in each block – that is each patient would have an equal chance of allocation to either group. Once the randomization phase was completed, all patients were instructed to follow-up the usual medical care for their diabetes for the duration of the 90 days trial. The patients were allowed to adjust their usual medications as recommended by their doctors. In addition, each patient was asked to go for blood test for HbA1c on day 1 and then return to give blood sample after 90 days. In addition, participants were advised not to take any other new treatments for the management of type 2 diabetes during the trial periods. The control group in randomized controlled trial received medical care from a physician-coordinated team. This team included physicians, nurses, dietitians, and mental health professionals with expertise and a special interest in diabetes. It is essential in this collaborative and integrated team approach that individuals with diabetes assume an active role in their care.
The management plan in that group was based on individualized therapeutic alliance among the patient and family, the physician, and other members of the health care team. This plan has recognized diabetes self-management education as an integral component of care and in developing the plan, consideration was given to the patient’s age, work schedule and conditions, physical activity, eating patterns, social situation and personality, cultural factors, and presence of complications of diabetes or other medical conditions. Patient self-management was emphasized, and the plan emphasized the involvement of the patient in problem-solving as much as possible. A variety of strategies and techniques were employed to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. During the implementation of the management plan it was assured that each aspect of diabetes management was understood and agreed on by the patient and the care providers and that the goals and treatment plan were reasonable. Those patients randomized to take fenugreek (intervention group) received 100 gms fenugreek seeds powder from the pharmacy in the clinic. They were instructed to take 50 gms doses twice a day at lunch and dinner time in addition to their normal medications for diabetes. Those patients randomized to usual medical care (control group) were instructed to take their normal medicines and follow-up with their doctor as per their normal schedule.
All participants were contacted again after 90 days (3-months) to give their blood sample for HbA1c testing. At that time, a questionnaire was sent via e-mail to participants in both intervention and control groups to assess the progress of the fenugreek treatment and clinical care without fenugreek. The clinical and demographic characteristics of the patients in the two groups were well balanced at randomization.
A demographic measure included age, gender, weight, ethnicity, religion, marital status, previous episodes of glycemic control, previous and current treatments of type 2 diabetes. The table 3 gives baseline characteristics of intervention and control groups in RCT trial. Diabetes treatment with medicationsThe treatment options of type 2 diabetes is shown in figure 4 suggesting the specific areas of actions using medications which influence the various organs of the body to correct the metabolic abnormalities such as reducing the liver glucose production, slowing down absorption of sugars from the gut and reducing the insulin resistance. There are currently six distinct classes of hypoglycemic agents available to treat type 2 diabetes. The patients in both the groups in RCT trials received medications recommended by their physicians. The most common combinations among both the groups were Meglitinide (repaglinide) with Thiazolidendiones and Sulfonylurea with Biguanides. Details of hypoglycaemic medications used in RCT trialThe diabetes medications mentioned in table 4 work in different ways but the main function of all these medications include lowering blood sugar levels; help improve the body’s use of glucose, decrease the symptoms of high blood sugar, help keeping patients with diabetes functioning normally and may prevent the complications, organ-damaging effects and premature deaths diabetes can cause. Since the drugs work in different ways, these are sometimes used in combination to enhance the effectiveness of treatment. In this RCT trial Sulfonylurea was used in combination with Biguanide (metformin) and Meglitinide was used in combination with Thiazolidinedione.
The main function of Sulfonylurea is to bind and inhibit the pancreatic ATP-dependent potassium channel that is normally involved in glucose-mediated insulin secretion.
Like the sulfonylurea, meglitinide therapy results in significant reduction in fasting glucose as well as HbA1c. The mechanism of action of the meglitinide is initiated by binding to a receptor on the pancreatic ?-cell that is distinct from the receptors for the sulfonylurea.
Metformin is a member of this class and is currently the most widely prescribed insulin-sensitizing drug in current clinical use. Metformin administration does not lead to increased insulin release from the pancreas and as such the risk of hypoglycemia is minimal.
Because the major site of action for metformin is the liver its use can be contraindicated in patients with liver dysfunction. Thiazolidinedione: The thiazolidinedione (pioglitazone) has proven useful in treating the hyperglycemia associated with insulin-resistance in both type 2 diabetes and non-diabetic conditions. The net effect of the thiazolidinedione is a potentiation of the actions of insulin in liver, adipose tissue and skeletal muscle, increased peripheral glucose disposal and a decrease in glucose output by the liver.
Diabetes treatment with diet and exerciseThe normal diabetes treatment addresses the issues related to unhealthy lifestyles, such as lack of physical activity and excessive eating, which are the main causes to initiate and propagate the majority of type 2 diabetes (Michael, 2007). Studies have demonstrated strong relationship between excess weight and the risk of developing type 2 diabetes, hypertension, and hyperlipidemia. Therefore, the objective of physicians is to motivate patients to lose weight and exercise to improve the control of diabetes and slow down or even reverse the natural course of the disease (Michael, 2007).However, it is difficult to overstate the importance of the relationship between lifestyle and the risk of developing type 2 diabetes. There are prospective studies which have demonstrated that lifestyle modification in the form of diet and regular moderate exercise sharply decrease the likelihood of developing type 2 diabetes in high-risk individuals who have impaired glucose tolerance or impaired fasting glucose. The effectiveness of this intervention superseded that of metformin therapy (Knowler et al. In this RCT trial, physicians compiled the flow scheme shown in Figure 5 which represents the method of treatment of type 2 diabetes by the combination of diet, exercise and medication for diabetes monitoring and control. It has been divided into two segments: for obese and normal weight patients and the combination of medication for both the groups of patients. Dietary consideration for patients (intervention and control group)It has been recommended that carbohydrate and monosaturated fat consumption for the patients with type 2 diabetes should comprise 60-70% of total calories. However, there is some concern that increased unsaturated fat consumption may promote weight gain in obese patients with type 2 diabetes and therefore may cause in reduction of insulin sensitivity (Bantle et al. The “glycemic index” is an attempt to compare the glycemic effects of various foods to a standard, such as white bread. Although several authors have proposed its clinical usefulness in controlling postprandial hyperglycemia, prospective studies have not demonstrated a clear improvement in hemoglobin (HbA1c) in patients using low-glycemic index diets (Michael, 2007).
The physicians in this trial have recommended the best mix of carbohydrate, protein, and fat that was adjusted to meet the metabolic goals and individual preference of the patients with diabetes in both the intervention and control groups.
It has been recommended for individuals with diabetes, that the use of the glycemic index and glycemic load may provide a modest additional benefit for glycemic control over that observed when total carbohydrate is considered alone (ADA, 2011).
Monitoring carbohydrate, whether by carbohydrate counting, choices, or experience-based estimation, remain a key strategy in achieving glycemic control. Physical activity consideration for patients (intervention and control group)Physical activity is a key component of lifestyle modification that can help individuals prevent or control type 2 diabetes. It is considered that diet is probably more important in the initial phases of weight loss, incorporating exercise as part of a weight loss regimen helps maintain weight and prevent weight regain (Klein et al. In this trial, the message was given to both the groups that as little as 30 minutes of moderate physical activity daily may offer greater benefits to these patients in managing their diabetes. It has also been reported that in patients with type 2 diabetes, structured regimens of physical activity for 8 weeks or longer improved HbA1c independent of changes in body mass (Sigal et al. The evidence supports the contention that controlling blood glucose through modification of diet and lifestyle should be mainstay of diabetes therapy.
It was found in this RCT that despite being one of the most time-consuming discussions with the patients in both the groups, this is probably the most important patient-physician discussion in regard to diabetes control and prevention of disease progression and complications. Statistical analysisWe analysed the primary outcome by an un-paired sample t-test (mean difference between baseline and final HbA1c). The statistical analysis was carried out on an intention to treat basis and that was subject to the availability of data at follow up as well as at entry level for individual patients.



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